Brain Metastases, Brain Tumor, Meningioma, Small Cell Lung Cancer
Conditions
Brief summary
The aim of the study is to evaluate whether open-face masks improve patient comfort/preference whilst maintaining immobilization performance as known for closed masks in patients undergoing whole or partial cranial radiotherapy.
Detailed description
Upon randomization, patients will be begin treatment either with an open-face mask (A) or closed mask (B). Two individual immobilization masks - the open-face and closed masks - will be fabricated for every single patient. During the 1st half of treatment the randomly assigned mask will be used followed by using another mask for the 2nd half of treatment. Discomfort/pain/anxiety and mask preference will be scored during treatment with a questionnaire.
Interventions
DEVICEHead immobilization mask
Immobilization
Sponsors
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent according to Swiss law and International Council for Harmonization (ICH)/Good Clinical Practice (GCP) regulations before any trial specific procedures; * Indication for cranial radiotherapy irrespective of tumor type; * Age: ≥ 18 years old; * Karnofsky performance status ≥70; * Patients who are willing and able to comply with scheduled visits, treatment, and other trial procedures.
Exclusion criteria
* Cranial radiotherapy in less than 10 fractions; * Prior brain irradiation; * Inability to complete magnetic resonance imaging (MRI) procedure due to claustrophobic anxiety; * Women who are pregnant or breast feeding; * Intention to become pregnant during the course of the trial; * Lack of safe contraception; * Known or suspected non-compliance, drug or alcohol abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient discomfort with the two immobilization masks | Change in patient discomfort through the course of radiation therapy, up to 6 weeks | Patient discomfort measured with the Visual Analogue Scale (VAS) 0-10 with no discomfort (scored as 0) and extreme discomfort (scored as 10). |
| Mask preference | At completion of radiation therapy, up to 6 weeks depending on radiation dose fractionation | Mask preference measured with the Yes/No questionnaire. Upon completion of radiation therapy patients will be asked which of the two immobilization masks they prefer - either Yes or No to one of the used masks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment set-up accuracy | Through the course of radiation therapy, up to 6 weeks | Measured with planar kilovoltage (kV) imaging |
| Treatment intra-fraction accuracy | Through the course of radiation therapy, up to 6 weeks | Measured with an optic surface imaging (OSI) system |
| Immobilization-mask-induced severe adverse events during treatment | From the baseline to 3 months post-treatment | Measured with CTCAE version 5.0 |
| Location of discomfort on the head/face | Changes in location of discomfort on the head/face through the course of radiation therapy up to 6 weeks | Measured with the questionnaire consisting of a head/face diagram divided in 8 regions |
Countries
Switzerland
Outcome results
None listed